Overview
Fostamatinib has been investigated for the treatment and basic science of Rheumatoid Arthritis and Immune Thrombocytopenic Purpura (ITP). It was approved on April 17, 2018, under the trade name Tavalisse for use in ITP . Fostamatinib has also been granted orphan drug status by the FDA . Recently, fostamatinib has been identified as a potential therapeutic for controlling acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 through its ability to modulate the SYK kinase.
Background
Fostamatinib has been investigated for the treatment and basic science of Rheumatoid Arthritis and Immune Thrombocytopenic Purpura (ITP). It was approved on April 17, 2018, under the trade name Tavalisse for use in ITP . Fostamatinib has also been granted orphan drug status by the FDA . Recently, fostamatinib has been identified as a potential therapeutic for controlling acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 through its ability to modulate the SYK kinase.
Indication
用于治疗对既往治疗反应不足的慢性免疫性血小板减少症（ITP）成年患者的血小板减少症。
Associated Conditions
- Chronic immune thrombocytopenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | Phase 1 | Not yet recruiting | |||
2025/01/03 | N/A | Recruiting | |||
2024/08/21 | Phase 2 | Not yet recruiting | |||
2024/01/31 | Phase 1 | Recruiting | Stefanie Sarantopoulos, MD, PhD. | ||
2023/10/06 | N/A | Completed | |||
2023/06/15 | Phase 1 | Recruiting | |||
2022/11/14 | N/A | Completed | |||
2022/10/25 | Phase 2 | Terminated | |||
2022/08/22 | Phase 2 | ENROLLING_BY_INVITATION | |||
2022/08/16 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rigel Pharmaceuticals, Inc. | 71332-002 | ORAL | 150 mg in 1 1 | 4/30/2018 | |
| Rigel Pharmaceuticals, Inc. | 71332-001 | ORAL | 100 mg in 1 1 | 4/30/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/9/2020 | ||
Authorised | 1/9/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TAVALISSE TABLETS 150MG | N/A | N/A | N/A | 10/28/2022 | |
| TAVALISSE TABLETS 100MG | N/A | N/A | N/A | 10/28/2022 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||